Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases
1 other identifier
interventional
20
1 country
1
Brief Summary
This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Sep 2024
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 7, 2024
CompletedFirst Posted
Study publicly available on registry
August 12, 2024
CompletedStudy Start
First participant enrolled
September 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 6, 2026
March 1, 2026
2.3 years
August 7, 2024
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
The incidence of adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESI) during treatment
2 years
Study Arms (1)
Intervention
EXPERIMENTALRD06-04；RD06-05
Interventions
CAR T-cell therapy administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
Eligibility Criteria
You may qualify if:
- The subjects voluntarily participated in the study and signed the informed consent form.
- Age ≥18 years old and ≤70 years old, both sexes.
- Organ function and laboratory tests:
- Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).
- Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml/min.
- Blood routine: neutrophil count ≥1×10\^9/L, hemoglobin ≥60g/L, platelet count ≥20×10\^9/L, lymphocyte count \>0.3×10\^9/L.
- Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.
- Oxygen saturation (SpO2) ≥92% at rest in room air.
- Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.
- Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.
- Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after CAR-T reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of CAR-T and had to refrain from donating semen or sperm throughout the trial.
- A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.
- Positive antinuclear antibodies (ANA) at screening, and/or positive anti-double-stranded DNA (anti-dsDNA) antibodies, and/or positive anti-Smith antibodies.
- A SLEDAI-2K score \>6 at screening, and a 'clinical' SLEDAI-2K score ≥4.
- Diagnosed with SSc according to the 2013 ACR/EULAR classification criteria.
- +8 more criteria
You may not qualify if:
- SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.
- IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.
- Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.
- There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.
- Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.
- Pregnant or breastfeeding women.
- Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Third the People's Hospital of Bengbu
Bengbu, Anhui, 233000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 7, 2024
First Posted
August 12, 2024
Study Start
September 14, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share